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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER,
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MIDMARK CORPORATION PREVA; UNIT, X-RAY, EXTRAORAL WITH TIMER, Back to Search Results
Model Number VETPRO COMPLETE
Device Problems Fracture (1260); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/26/2015
Event Type  malfunction  
Event Description
On (b)(6) 2015, it was reported to midmark that an x-ray unit (vetpro complete unit, serial number (b)(4)) separated from its wall mounting at a veterinary user facility in (b)(6).The x-ray technician was extending the arm and one of the two fasteners (long socket cap screws) that bolt the control unit to the wall plate fractured, causing the control unit to rotate sideways and the device to fall.No injuries were reported.Photos of the incident were provided to midmark by the user facility, and the unit was re-installed with new fasteners.
 
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Brand Name
PREVA
Type of Device
UNIT, X-RAY, EXTRAORAL WITH TIMER,
Manufacturer (Section D)
MIDMARK CORPORATION
675 heathrow dr.
lincolnshire, il 60069, us 60069
Manufacturer Contact
adam foresman
675 heathrow drive
lincolnshire, IL 60069
8474159739
MDR Report Key4865123
MDR Text Key5810303
Report Number1423380-2015-00015
Device Sequence Number1
Product Code EHD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K043092
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 05/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Radiologic Technologist
Device Model NumberVETPRO COMPLETE
Device Catalogue NumberDCV6-G2A/S2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/26/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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